eligibility_summary
Eligibility: ≥18, consent. Refractory solid tumors, expansion: NSCLC (≥2 lines, PD‑L1+ prior IO, actionable mutations had targeted tx) or HER2‑neg/low breast cancer (≥1 line, PD‑L1+ TNBC prior IO, HR+ prior CDK4/6). Requires TROP2 IHC 2+/3+, ECOG 0‑1, measurable disease, adequate organs, LVEF>50%, O2>92%. Excludes pregnancy/breastfeeding, recent therapy/live vaccines, prior CAR T/NK, immunodef/steroids, CNS mets, autoimmune, ILD, infections (HIV/HBV/HCV/TB), major CV disease/QTc>480, bleeding risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: 1) TROP2‑CAR‑NK cells: allogeneic cord blood–derived, gene‑engineered NK cell therapy expressing an anti‑TROP2 CAR and transduced with IL‑15, mechanism: CAR engagement of TROP2 triggers NK cytotoxicity (perforin/granzymes), while IL‑15 autocrine signaling sustains survival, proliferation, and in vivo persistence. 2) Rimiducid (AP1903): small‑molecule dimerizer that activates an inducible caspase‑9 safety switch to ablate the engineered cells if needed. 3) Fludarabine phosphate: purine‑analog antimetabolite for lymphodepletion. 4) Cyclophosphamide: alkylating agent for lymphodepletion. Targets/pathways: TROP2 (TACSTD2) on TROP2‑high solid tumors (NSCLC, HER2‑negative/low breast), CAR‑mediated NK activation, IL‑15/JAK‑STAT survival pathway, depletion of host lymphocytes/Tregs to enable engraftment.